Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pulmonary Care Web-Based App (HappyAir App)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- COPD patient.
- Aged between 55 and 85 years.
- Degree of severity II, III, or IV of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) scale.
- Stable clinical situation (no exacerbations in the last 6 weeks).
Exclusion Criteria:
- Unstable cardiovascular disease or muscular, osteoarticular, auditory, visual, or central or peripheral nervous system impairment that prevents the performance of the rehabilitation program or evaluation tests.
- Cognitive impairment that makes it difficult to understand the education program and manage the HappyAir system
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HappyAir Group
Control group
Arm Description
The HappyAir app comprises two main parts: an educational program providing patients useful information and advice about their illness and data collection related to physical activity and disease.
The control group only underwent the scheduled check-ups
Outcomes
Primary Outcome Measures
Treatment Adherence
Adherence to the maintenance program was measured with the respiratory physiotherapy adherence self-report questionnaire (CAP PHYSIO).
It consists of a total of 16 items, with a Likert scale to score each one, with 1 point as totally disagree and 4 points as totally agree. Three different dimensions of results are obtained: Total CAP, Perception and Adherence. The final rating scale is set to a range of minimum of 16 points (minimum adherence) to a maximum of 64 points (maximum adherence).
Secondary Outcome Measures
Adherence to physical activity
Adherence to physical activity was measured with the therapeutic compliance questionnaire (Morisky-Green Test).
It consists of a series of four contrast questions with a "yes/no" dichotomous answer, which reflects the patient's behavior with respect to compliance. It results in a score ranging from 0 (High adherence) to 4 (Low adherence).
Self-reported Quality of Life: EuroQOL-5D
Quality of life was measured with three different self-reported questionnaires, including the Chronic Obstructive Pulmonary Disease Assessment Test, St. George's Respiratory Questionnaire and EuroQOL-5D
Exercise Capacity
Exercise capacity was measured with the 6-Minute Walk Test (6MWT)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04479930
Brief Title
Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Development and Preliminary Evaluation of the Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CEU San Pablo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objective: This study aimed to assess the effects of an integrated care plan based on an mHealth web-based platform (HappyAir) on adherence to a 1-year maintenance program applied after pulmonary rehabilitation in COPD patients.
Methods: COPD patients from three hospitals were randomized to a control group or an intervention group (HappyAir group). Patients from both groups received an 8-week program of pulmonary rehabilitation and educational sessions about their illness. After completion of the process, only the HappyAir group completed an integrated care plan for 10 months, supervised by an mHealth system and therapeutic educator. The control group only underwent the scheduled check-ups. Adherence to the program was rated using a respiratory physiotherapy adherence self-report (CAP FISIO) questionnaire. Other variables analyzed were adherence to physical activity (Morisky-Green Test), quality of life (Chronic Obstructive Pulmonary Disease Assessment Test, St. George's Respiratory Questionnaire, and EuroQOL-5D), exercise capacity (6-Minute Walk Test), and lung function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HappyAir Group
Arm Type
Experimental
Arm Description
The HappyAir app comprises two main parts: an educational program providing patients useful information and advice about their illness and data collection related to physical activity and disease.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group only underwent the scheduled check-ups
Intervention Type
Other
Intervention Name(s)
Pulmonary Care Web-Based App (HappyAir App)
Intervention Description
The HappyAir app reminded the HappyAir group daily to use the app, indicating that they record medication intake, daily exercise time (minutes), level of tiredness after the exercises (good, little tired, very tired, or exhausted), and daily mood (happy, little sad, sad, or very sad). The HappyAir integrated plan was designed as a model of a therapeutic program based on communication that introduced the figure of the therapeutic educator (physiotherapist or respiratory coach) in order to design interventions focused on the patients and their needs, with minimal intervention and presence, making the patients responsible for their self-care and management of their illness. Patient and educator shared responsibility.
Primary Outcome Measure Information:
Title
Treatment Adherence
Description
Adherence to the maintenance program was measured with the respiratory physiotherapy adherence self-report questionnaire (CAP PHYSIO).
It consists of a total of 16 items, with a Likert scale to score each one, with 1 point as totally disagree and 4 points as totally agree. Three different dimensions of results are obtained: Total CAP, Perception and Adherence. The final rating scale is set to a range of minimum of 16 points (minimum adherence) to a maximum of 64 points (maximum adherence).
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Adherence to physical activity
Description
Adherence to physical activity was measured with the therapeutic compliance questionnaire (Morisky-Green Test).
It consists of a series of four contrast questions with a "yes/no" dichotomous answer, which reflects the patient's behavior with respect to compliance. It results in a score ranging from 0 (High adherence) to 4 (Low adherence).
Time Frame
10 months
Title
Self-reported Quality of Life: EuroQOL-5D
Description
Quality of life was measured with three different self-reported questionnaires, including the Chronic Obstructive Pulmonary Disease Assessment Test, St. George's Respiratory Questionnaire and EuroQOL-5D
Time Frame
10 months
Title
Exercise Capacity
Description
Exercise capacity was measured with the 6-Minute Walk Test (6MWT)
Time Frame
10 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD patient.
Aged between 55 and 85 years.
Degree of severity II, III, or IV of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) scale.
Stable clinical situation (no exacerbations in the last 6 weeks).
Exclusion Criteria:
Unstable cardiovascular disease or muscular, osteoarticular, auditory, visual, or central or peripheral nervous system impairment that prevents the performance of the rehabilitation program or evaluation tests.
Cognitive impairment that makes it difficult to understand the education program and manage the HappyAir system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Begoña Jimenez Reguera, Msc
Organizational Affiliation
CEU San Pablo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32513646
Citation
Jimenez-Reguera B, Maroto Lopez E, Fitch S, Juarros L, Sanchez Cortes M, Rodriguez Hermosa JL, Calle Rubio M, Hernandez Criado MT, Lopez M, Angulo-Diaz-Parreno S, Martin-Pintado-Zugasti A, Vilaro J. Development and Preliminary Evaluation of the Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e18465. doi: 10.2196/18465.
Results Reference
derived
Learn more about this trial
Effects of an mHealth Web-Based Platform (HappyAir) on Adherence to a Maintenance Program After Pulmonary Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease
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